former GlaxoSmithKline biostatistics manager has filed a whistleblower lawsuit accusing the drug maker of firing him for alleging dodgy study data was used to tout the effectiveness of a smoking-cessation product.
Alexandre Selmani, who worked at Glaxo for nearly a decade, claims his supervisors ignored repeated efforts to alert them to statistical mistakes made in clinical trials for NiQuitin, according to the lawsuit, which was filed in a New Jersey state court. In the United States, Glaxo markets the product as Nicoderm.
As a result, he claims the company engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment. The lawsuit also alleges Glaxo maintained its product was superior to existing nicotine treatments.
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Selmani began complaining about the data in mid-2012. But after meeting resistance, he claims to have sent an email to Glaxo Chief Executive Andrew Witty to warn that the mistakes had “the capacity to cause negative consequences and potential health and safety issues for the general public,” the lawsuit argues, although it does not allege any consumers were harmed.
Along with the drug maker, the lawsuit also names Witty and several employees as defendants. A Glaxo spokeswoman declined to comment.
[UPDATE: The Glaxo spokeswoman said the company had not been served, but that “we stand fully behind Nicoderm as a safe and effective form of smoking cessation which continues to help people to quit. GSK goes to great lengths to promote ethics and compliance in the workplace and has mandatory training to ensure all of our employees adhere to the highest standards of integrity. We also continually educate our employees about how they can report complaints so they can be appropriately investigated.”]
Despite Selmani’s protests, the company submitted the data for publication and the study was eventually published online in Psychopharmacology in April 2014. The study abstract concluded the product “could be useful to provide quick craving relief for low-dependence smokers.”
In his suit, Selmani maintains that his supervisors retaliated against him by giving him low job performance ratings and reduced raises; sabotaging some of his work; and, ultimately, firing him last October. His lawsuit cites the New Jersey Conscientious Employee Protection Act, which addresses retaliation by employers.
“The company wanted to use flawed data to sell the product to the public,” Rosemarie Arnold, his attorney, told us. “And when he brought that to the attention of his supervisor, he was basically told to shut up. He worked there many years, got great reviews, and did a great job. But they tried to push him out when he complained they used improper data. And consumers paid for something they didn’t get.”
According to the lawsuit, Selmani’s supervisor told him that he was wasting his time to report the mistakes because he would never be able to convince management to fix them. At one point, Selmani was also told that his “future was not with GSK.” His salary at the time he was fired was $134,000, the lawsuit states.
This story was updated to reflect an additional statement from Glaxo the day after the post was first published.